Particle Characterization Core Facility

Extensive Expertise in Particle Detection Methodology and In-Depth Particle Data Analysis

Our Particle Characterization Core Facility provides specialized, state-of-the-art analysis for subvisible particles ranging in size from nanometer to micron.

Significant improvements in analytical technology to quantify and characterize subvisible (1 – 100 µm) and submicron particles (≤1 µm) have prompted the regulatory agencies to require characterization of particles in these size ranges.

Multiple orthogonal methods are required to span the entire range and to accurately characterize the particle profile, as each instrument possesses limitations based on the detection strategy and sample solution properties. These limitations must be well understood to generate high-quality data.

KBI Biopharma has kept pace with technological advances, and over the years has developed extensive expertise in particle detection methodology, as well as in-depth particle data analysis.

Characterization & Identification

Particle Identification
Particle Profile Establishment
Biosimilarity/Comparability
Product Stability
Regulatory Support

Method Development

Biologics
Small Molecule
Materials

Particle Characterization